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FDA 510(k)

CALG-STR EXERCISE ECG ANALYSIS ALGORITHM

K-Number: K112959 · 2012-01-26

ApplicantPhilips Health Care
Decision Date2012-01-26
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CALG-STR EXERCISE ECG ANALYSIS ALGORITHM is the device name listed in this FDA 510(k) record. The listed applicant is Philips Health Care. It received FDA 510(k) clearance on 2012-01-26 under 510(k) number K112959. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CALG-STR EXERCISE ECG ANALYSIS ALGORITHM?

CALG-STR EXERCISE ECG ANALYSIS ALGORITHM is a medical device that received FDA 510(k) clearance on 2012-01-26. The listed applicant is Philips Health Care. The 510(k) number is K112959.

When did CALG-STR EXERCISE ECG ANALYSIS ALGORITHM receive FDA 510(k) clearance?

CALG-STR EXERCISE ECG ANALYSIS ALGORITHM received FDA 510(k) clearance on 2012-01-26, under 510(k) number K112959.

Who is the listed applicant for CALG-STR EXERCISE ECG ANALYSIS ALGORITHM?

The FDA 510(k) record lists Philips Health Care as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CALG-STR EXERCISE ECG ANALYSIS ALGORITHM?

The FDA product code for CALG-STR EXERCISE ECG ANALYSIS ALGORITHM is DPS.

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Related Devices (Code: DPS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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